Securing an implanted medical device in a patient

ABSTRACT

An apparatus and method for implanting and securing an implanted medical device in a recipient. The implantable medical device of the generally includes an electrode assembly that comprises an elongate carrier member having at least one stimulating electrode positioned thereon. The carrier member further has a fixation structure positioned thereon configured to interact with a portion of the rigid structure to longitudinally secure the carrier member in the recipient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation application of U.S. patentapplication Ser. No. 12/052,193, filed Mar. 20, 2008, naming PeterGibson as an inventor, which claims priority to U.S. Provisionalapplication No. 60/918,917, filed Mar. 20, 2007. The entire contents ofthese applications are incorporated herein by reference in theirentirety.

BACKGROUND

Field of the Invention

The present invention relates generally to medical devices, and moreparticularly, to securing an implanted medical device in a patient.

Related Art

Hearing loss is generally of two types, namely conductive andsensorineural. The treatment of both types of hearing loss has beenquite different, relying on different principles to enable soundpercepts to be generated in a recipient's brain. Conductive hearing lossoccurs when the normal mechanical pathways for sound to reach the haircells in the cochlea are impeded, for example, by damage to theossicles. In such cases, hearing is often improved with the use ofconventional hearing aids. Such hearing aids amplify sound so thatacoustic information reaches the hair cells of the cochlea. Typically,conventional hearing aids utilize acoustic mechanical stimulation,whereby the sound is amplified according to a number of varyingtechniques, and delivered to the inner ear as mechanical energy. Thismay be, for example, through a column of air to the eardrum, or throughdirect delivery to the ossicles of the middle ear.

Sensorineural hearing loss is due to the absence or destruction of thecochlear hair cells which are needed to transduce acoustic signals intoauditory nerve impulses. Individuals suffering from this type of hearingloss are unable to derive any benefit from conventional hearing aidsregardless of the magnitude of the acoustic mechanical stimulus. In suchcases, Cochlear™ implants (also referred to as Cochlear™ devices,Cochlear™ prostheses, Cochlear™ implant systems, and the like; simply“cochlear implants” herein) have been developed to provide hearingpercepts to such individuals. Cochlear implants provide electricalstimulation via stimulating electrodes positioned as close as possibleto the nerve endings of the auditory nerve, essentially bypassing thecochlear hair cells. The application of a stimulation pattern to thenerve endings causes impulses to be sent to the brain via the auditorynerve, resulting in the brain perceiving the impulses as sound.

It is relatively common for some hearing impaired individuals toexperience profound hearing loss for high frequency sounds, and yetstill be able to discern middle-to-low frequency sounds. Traditionally,such individuals typically do not receive a cochlear implant, as notedabove, due to the potential trauma caused by the implantation of atraditional electrode assembly into the cochlea. Rather, in the majorityof such cases, such an individual receives treatment to preserve andimprove hearing in the middle-to-low frequency range, typically via aconventional hearing aid. Minimal effort would be expended to restorehearing in the high frequency range. Unfortunately, such individualsgenerally experience poor restoration of their hearing with conventionalhearing aids alone.

Recently, there has been an increased interest in assisting individualswith residual hearing who do not experience adequate restoration fromconventional hearing aids alone. One proposed approach for assistingthese individuals is through the use of Electro-Acoustical Stimulation(EAS). So called EAS devices provide electrical stimulation of thecochlea in conjunction with acoustical stimulation.

SUMMARY

In one aspect of the invention, an electrode assembly for implantationinto a recipient through an opening in a reference structure in therecipient, comprising: an elongate carrier member, having proximal and adistal ends and at least one electrode disposed along the carriermember; and an integrated fixation structure constructed and arranged tointeract with the reference structure to when the carrier member isimplanted in the recipient, wherein the interaction prevents substantialtranslation of the carrier member.

In another aspect of the invention, a method of implanting a stimulatingmedical device, comprising: preparing an appropriately configuredopening in an internal reference structure of a recipient forimplantation of an elongate carrier member therethrough; inserting thecarrier member through the opening in the recipient; and allowing afixation structure positioned on the carrier member to interact with aportion of the structure to longitudinally secure the carrier member inthe recipient.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present invention are described hereinwith reference to the accompanying figures, in which:

FIG. 1 is a perspective view of an example of an implanted cochlearimplant suitable for implementing embodiments of the present invention;

FIG. 2A is a side view of an electrode assembly in accordance with oneembodiment of the present invention shown prior to insertion into acochlea;

FIG. 2B is a side view of the electrode assembly illustrated in FIG. 2A,shown inserted into a cochlea;

FIG. 3 is a perspective view of a recipient illustrating the location ofimplantation of an electrode assembly in accordance with embodiments ofthe present invention;

FIG. 4 is a side view of one embodiment of the electrode assemblyillustrated in FIGS. 2A and 2B;

FIGS. 5A-5H are cross section and side views of the fixation structureillustrated in FIGS. 2A and 2B, in accordance with certain embodimentsof the present invention;

FIG. 6 is a perspective view of a recipient illustrating the locationand orientation of the clithridiate opening utilized with embodiments ofthe present invention;

FIG. 7A is a side view of one embodiment of the electrode assemblyillustrated in FIGS. 2A and 2B;

FIG. 7B is a side view of on embodiment of the electrode assemblyillustrated in FIG. 7A;

FIGS. 8A-8D are cross sectional and side views of embodiments of afixation structure in accordance with certain embodiments of the presentinvention;

FIG. 9A is a perspective view of a recipient illustrating the locationand orientation of a bracket used to cooperate with embodiments of thepresent invention;

FIG. 9B is a partial cross-sectional view of a recipient illustratingthe location and orientation of another bracket used to cooperate withembodiments of the present invention; and

FIG. 10 is a side view of one embodiment of the electrode assemblyillustrated in FIGS. 7A and 7B cooperating with a bracket.

DETAILED DESCRIPTION

Embodiments of the present invention are generally directed to securingan implantable medical device in a patient (also referred to as arecipient). Certain embodiments are described herein in connection withone type of implantable medical device, a prosthetic hearing implantand, more specifically, a cochlear implant. Cochlear implants use directelectrical stimulation of auditory nerve cells to bypass absent ordefective hair cells that normally transduce acoustic vibrations intoneural activity. Such devices generally use multi-contact electrodesinserted into the scala tympani of the cochlea so that the electrodesmay differentially activate auditory neurons that normally encodedifferential pitches of sound. These devices are also used to treat asmaller number of recipients with bilateral degeneration of the auditorynerve. Such devices are described in commonly owned and co-pending U.S.patent application Ser. No. 11/605,952, filed Nov. 30, 2006, (nowabandoned) and Ser. No. 11/605,951, filed Nov. 30, 2006, (now U.S. Pat.No. 7,937,154, issued May 3, 2011), which are hereby incorporated byreference herein. For such recipients, a cochlear implant providesstimulation of the cochlear nucleus in the brainstem. Such devices,therefore, are commonly referred to as auditory brainstem implants(ABis).

Although some embodiment of the present invention are described hereinwith reference to a particular type of cochlear implant, it should beunderstood that embodiments of the present invention may be implementedin connection with all forms of cochlear implants. Furthermore, itshould be understood by those of ordinary skill in the art thatembodiments of the present invention may be implemented in stimulatingmedical devices other than cochlear implants such as neurostimulators,cardiac pacemakers/defibrillators, etc. as well as other medical deviceswhich utilize a carrier member to temporarily or permanently implant,deliver or otherwise introduce into a recipient a therapeutic agent,sensor, electrodes or other active or passive components now or laterdeveloped.

Exemplary embodiments of a cochlear implant utilized in accordance withembodiments of the present invention include a Contour™, Freedom™,Nucleus™ or Cochlear™ implant sold by Cochlear Limited, Australia. Suchdevices are described in U.S. Pat. Nos. 4,532,930, 6,537,200, 6,565,503,6,575,894, and 6,697,674, which are hereby incorporated by referenceherein. Similarly, cochlear implants utilizing a short electrode arrayare described in commonly owned and co-pending U.S. patent applicationSer. Nos. 11/605,952 and 11/605,951, which are hereby incorporated byreference herein.

FIG. 1 is a cut-away view of the relevant components of outer ear 101,middle ear 102 and inner ear 103, with an exemplary cochlear implant120. In a fully functional ear, outer ear 101 comprises an auricle 105and an ear canal 106. An acoustic pressure or sound wave 107 iscollected by auricle 105 and channeled into and through ear canal 106.Disposed across the distal end of ear cannel 106 is a tympanic membrane104 which vibrates in response to acoustic wave 107. This vibration iscoupled to oval window, or fenestra ovalis, 110 through three bones ofmiddle ear 102, collectively referred to as the ossicles 111.

Ossicles 111 comprise malleus 112, incus 113 and stapes 114. Bones 112,113 and 114 of middle ear 102 serve to filter and amplify acoustic wave107, causing oval window 110 to articulate, or vibrate. Such vibrationsets up waves of fluid motion within cochlea 115. Such fluid motion, inturn, activates tiny hair cells (not shown) that line the inside ofcochlea 115. Activation of the hair cells causes appropriate nerveimpulses to be transferred through the spiral ganglion cells (not shown)to auditory nerve 116 and, ultimately, to the brain where they areperceived as sound. In some persons experiencing sensorineural hearingloss, there is an absence or destruction of the hair cells. Cochlearimplant 120 is utilized to directly stimulate the ganglion cells toprovide a hearing sensation to such persons.

FIG. 1 also shows how cochlear implant 120 is positioned in relation toouter ear 101, middle ear 102 and inner ear 103. Cochlear implant 120comprises external component assembly 122 which is directly orindirectly attached to the body of the recipient, and an internalcomponent assembly 124 which is temporarily or permanently implanted inthe recipient. External assembly 122 comprises microphone 125 fordetecting sound which is provided to a behind-the-ear (BTE) speechprocessing unit 126 that generates coded signals. The coded signals areprovided to an external transmitter unit 128, along with power from apower source (not shown) such as a battery. External transmitter unit128 comprises an external coil 130 and, preferably, a magnet (not shown)secured directly or indirectly in external coil 130.

Internal component assembly 124 comprises an internal receiver unit 132having an internal coil (not shown) that transcutaneously receives powerand coded signals from external assembly 122, and provides such signalsto a stimulator unit 134. In response to the coded signals, stimulator134 applies stimulation signals to cochlea 115 via an electrode assembly140 implanted through temporal bone 160. Electrode assembly 140 enterscochlea 115 via an opening of the perilymphatic spaces of cochlea 115,referred to as cochleostomy 142, and has an array 144 of one or moreelectrodes 150 positioned to be substantially aligned with portions oftonotopically-mapped cochlea 115. The delivery of stimulation signals atvarious locations along cochlea 115 causes a hearing perceptrepresentative of the received sound 107.

While cochlear implant 120 is described as having external components,in another embodiment, the controller, including the microphone, speechprocessor and power supply, may also be implantable. In suchembodiments, the controller may be contained within a hermeticallysealed housing or the housing used for stimulator unit 134.

Electrode assembly 140 preferably assumes an optimal electrode positionin cochlea 115 upon or immediately following implantation into thecochlea. It is also desirable that electrode assembly 140 be configuredsuch that the insertion process causes minimal trauma to the sensitivestructures of cochlea 115. Typically, electrode assembly 140 ispre-curved, held in a substantially straight configuration at leastduring the initial stages of the implantation procedure, then conformingto the natural shape of the cochlea during, and subsequent to,implantation.

FIGS. 2A and 2B are side views of an embodiment of electrode assembly140, referred to herein as electrode assembly 200. In FIG. 2A, theelectrode assembly is illustrated prior to insertion in a recipient'scochlea; FIG. 2B, following insertion. Electrode assembly 200 comprisesa carrier member 202 having a proximal end 208 and a distal end 210.Distal end 210 terminates in tip 211, and is adapted to be implantedfurthest into cochlea 115. A plurality of spaced-apart electrodes 212are mounted or disposed on or in carrier member 202. Electrodes 212 areembodiments of electrodes 144 (FIG. 1). It should be appreciated that asused herein, particular combinations of the terms mounted/disposed,in/on, etc., are not to be interpreted to refer to any particularmanufacturing technique or structural relationship.

Attached to or integral with carrier member 202 are a stop member 240and a fixation structure 250. Fixation structure 250 is positioned oncarrier member 202 at or near proximal end 208 of carrier member 202.Fixation structure 250 is described in greater detail below withreference to FIGS. 4-10. Stop member 240 is positioned on carrier member202 between fixation structure 250 and all, and, in embodiments in whichnot all electrodes 212 are to be inserted into cochlea 115, some of theelectrodes.

Extending from proximal end 208 of carrier member 202 is a lead 214.Lead 214 physically and electrically connects electrode assembly 200with stimulator unit 134 (FIG. 1).

As shown in FIG. 2B, carrier member 202 may be implanted into cochlea115 through an aperture in the cochlea. The aperture may be oval window110, round window 141 or a surgical incision 142. In this description,reference will be made to round window 141 (FIG. 1); it should beappreciated, however, that other embodiments of the present inventionmay be configured to be implanted in oval window 110 or other natural orman-made aperture in cochlea 115. Carrier member 202 is inserted intocochlea 115 until stop member 240 contacts an exterior surface ofcochlea 115 surrounding round window 141, when Abutting cochlea 115member 240 at least partially prevents perilymphatic fluid from escapingfrom cochlea 115.

When implanted, the surface of carrier member 202 which faces theinterior of cochlea 115 is referred to herein as the medial surface 216of carrier member 202. The opposing side of carrier member 202, referredto herein as lateral surface 218, faces the external wall and bonycapsule (not shown) of cochlea 115. It should be understood that theterms medial surface, medial direction, and the like, are generally usedherein to refer to the surfaces, features and directions toward thecenter of cochlea 115, while the terms lateral surface, lateraldirection, and the like, are generally used herein to refer to surfaces,features and directions toward the exterior of cochlea 115.

As would be appreciated by those of ordinary skill in the art,electrodes 212 may be disposed in a linear or non-linear array on or incarrier member 202, and are typically positioned on or in carrier member202 so as to align with predetermined regions of tonotopically mappedcochlea 115 when implanted in cochlea 115. In alternative embodiments,electrodes 212 are implemented as described in U.S. Provisional PatentApplications 60/748,217, filed Dec. 8, 2005, 60/748,273 filed Dec. 8,2005, and 60/748,314, filed Dec. 8, 2005, which are hereby incorporatedby reference herein.

In one embodiment, electrodes 212 are half-band electrodes disposed inor on medial surface 216 of carrier member 202. It should beappreciated, however, that any electrodes now or later developedsuitable for a particular application may be used in alternativeembodiments of the invention. For example, in one alternativeembodiment, electrodes 212 are banded electrodes extending substantiallyaround the circumference of carrier member 202. In another embodiment,electrodes 212 do not laterally extend to or around the edges of carriermember 202. Typically, each electrode 212 is arranged such that itsexposed surface is substantially parallel to a longitudinal axis 224 ofcarrier member 202. It should be appreciated, however, that otherlocations and orientations may be implemented in alternativeembodiments. It should further be appreciated that the quantity ofelectrodes 212 may vary from as few as one or two to as many astwenty-four or more.

In certain embodiments, at least one electrode 212 has a surface that isat least adjacent medial surface 216 of carrier member 202. Preferably,one or more electrodes 212 has a surface that is collocated with medialsurface 216 of carrier member 202. In another embodiment, the surfacesof electrodes 212 are raised above or recessed into the surface 216 ofcarrier member 202. It should be appreciated, however, that anyembodiment of electrodes 212 may be implemented.

In certain embodiments, electrodes 212 are manufactured from abiocompatible conductive material such as platinum, although othermaterials or combinations of materials may be used. In certainalternative embodiments electrodes 212 are coated with a biocompatiblecovering that does not interfere with the transfer of stimulationsignals to cochlea 115.

A variety of surgical methods may be used to implant an electrodeassembly in a recipient, including a mastoidectomy and facial recessapproach, a transcanal approach, or a combination thereof, dependingupon the particular recipient anatomy, recipient needs and surgeon'sdiscretion. For ease of description, embodiments of the presentinvention will be described with reference to implantation using afacial recess approach.

Referring again to FIG. 1, in an implantation procedure utilizing thefacial recess approach, electrode assembly 140 is inserted during anoperation that usually takes between 2-3 hours, depending on the deviceto be implanted. An incision is made behind outer ear 101 to exposetemporal bone 160. Temporal bone 160 consists of several segments (notshown) known as the squamous, the mastoid, the tympanic, the zygomaticand the petrous segment. Typically, traditional cochlear implantsrequire the opening of the mastoid segment of temporal bone 160 whichleads to middle ear 102.

Following the opening of the incision behind outer ear 101, a shallowrecess is created in the mastoid to hold implanted receiver 132 andstimulator 134. Next, additional amounts of the mastoid are removed. Byremoving this additional portion of the mastoid, the surgeon opens anarea known as the facial recess. The facial recess is a concave portionof the inner side of the mastoid bone that opens to middle ear 102, andinner ear 103. As the facial recess is opened, the surgeon is able toaccess middle ear 102 and inner ear 103.

The surgeon then prepares an opening in cochlea 115 to allowimplantation of electrode assembly 140 into cochlea 115. The opening maybe formed through round window 141, oval window 110, the promontory orthrough the apical turn of the cochlea. Electrode assembly 140 is thengently threaded into the shell-like structure of the cochlea. Dependingin the type of implant used, the opening may either remain open to healwith scar tissue, or may be closed by the surgeon. The procedure iscompleted by closing the incision behind outer ear 101.

FIG. 3 illustrates a perspective view of the right side of a recipientshowing the location of implantation of certain embodiments of theelectrode assembly of the present invention in accordance with thefacial recess approach. It should be appreciated, however, thatembodiments of the present invention are equally applicable to otherimplantation methods. Directional arrows 330, 332, 334 and 336illustrate general directions in relation to the recipient. Directionalarrow 330 illustrates the inferior direction, and refers to a directionthat is towards the feet of the recipient. Directional arrow 332illustrates the posterior direction, and refers to a direction that istowards the back of the recipient's head. Directional arrow 334illustrates the superior direction, and refers to a direction that istowards the top of the recipient's head. Directional arrow 336illustrates the anterior direction, and refers to a direction that istowards the front of the recipient's head.

As illustrated in FIG. 3, facial recess 362 is positioned between thefacial nerve 310 and the cord-tympani nerve 312. Facial nerve 310 ispositioned posterior to facial recess 362, and cord-tympani nerve 312 ispositioned anterior to facial recess 362. Visible behind facial recess362 is round window 141 of cochlea 115. In some embodiments of thepresent invention, electrode assembly 200 is configured to be implantedthrough facial recess 362 and into round window 141.

An implanted electrode assembly, such as electrode assembly 140, mayhave a tendency to migrate out of cochlea 115 following implantation.This may be due to the materials used for the construction of theelectrode assembly, as well as the bias of the electrode assembly. Forexample, as a straight electrode assembly is inserted into cochlea 115,and thereby forced into a spiraled configuration, the electrode assemblyattempts to return to a straight configuration. The forces applied bythe electrode assembly to return to a straight configuration may causethe electrode assembly to migrate out of the cochlea. Another cause ofsuch migration out of cochlea 115 is the inadvertent pulling of theelectrode assembly during subsequent steps of the surgery. Anotherpotential cause is when the electrode assembly has a spring force whichif not properly stabilized. The spring force may tend to pull theelectrode assembly out over a long period of time.

FIG. 4 is a side view of one embodiment of electrode assembly 140,referred to herein as electrode assembly 400, configured to reduce theability of electrode assembly 400 to exit cochlea 115 followingimplantation. In FIG. 4, electrode assembly 400 is shown in an implantedposition, and is viewed from an anterior direction of the recipient.Electrode assembly 400 comprises a carrier member 202, having proximalend 208 and distal end 210, terminating in tip 211. A plurality ofspaced-apart electrodes 212 are disposed in carrier member 202 alongmedial surface 216 of carrier member 202. The opposing side of carriermember 202 is referred to herein as lateral surface 218. Lead 214extends from proximal end 208.

Attached to or integral with carrier member 202 are stop member 240 asdescribed with reference to FIGS. 2A and 2B, and fixation structure 450.Fixation structure 450 is positioned at or near proximal end 208 ofcarrier member 202 to substantially interact with at least a portion ofthe bone surrounding facial recess 362. In the specific embodiment shownin FIG. 4, fixation structure 450 comprises a series ofcircumferentially-extending projections 470. Ifcircumferentially-extending projections 470 are viewed along a planethat extends longitudinally through fixation structure 450, eachprojection may have, for example, a substantially triangularcross-sectional shape.

In FIG. 4, circumferentially-extending projections 470 are dimensionedto extend from carrier member 202 to bone 160 surrounding facial recess362. The above-noted tendency of electrode assembly 400 to exit cochlea115 places pressure on fixation structure 450 to exit the recipient.However, the pressure from carrier member 202 causescircumferentially-extending projections 470 to further interact withbone 160. This interaction produces a longitudinal anchor force thatsubstantially prevents longitudinal movement (that is, movement in adirection approximately parallel to the longitudinal axis of the device)of fixation structure 450 out of the recipient. This resultinglongitudinal anchor force is a force along the longitudinal axis ofelectrode assembly 400 in the direction of cochlea 115. The longitudinalanchor force maintains fixation structure 450 in bone 160 therebyretaining carrier member 202 in a desired position in cochlea 115. Inother words, the longitudinal anchor force prevents substantiallongitudinal movement of carrier member 202 out of cochlea 115.

As noted, embodiments of electrode assembly 400 may include half-bandelectrodes. For optimal stimulation, an electrode assembly utilizinghalf-band electrodes is preferably maintained in a desired position andorientation within cochlea 115. However, due to certain aspects of theimplantation procedure, a rotational force may be created on electrodeassembly 400 that causes electrode assembly 400 to twist within cochlea115. If electrode assembly 202 twists within cochlea 115, the half bandelectrodes will no longer be in a desired orientation for optimalstimulation. In such embodiments, fixation structure 450 may beconfigured to produce an additional anchor force that prevents rotationof electrode assembly 400 within cochlea 115. This additional anchorforce is referred to herein as a rotational anchor force. As electrodeassembly 400 attempts to twist within cochlea 115, the torque causescircumferentially-extending projections 470 to further interact withbone 160. This additional interaction produces a rotational anchor forcethat substantially prevents rotational movement of fixation structure450. As a result of this rotational anchor force rotational movementsubstantial of carrier member 202 is also prevented.

In certain embodiments, fixation structure 450 comprises a flexiblematerial having a diameter that is larger than facial recess 362. Insuch embodiments, during implantation, flexible fixation structure 450is forced in to facial recess 362 and is compressed therein. As fixationstructure 450 attempts to exit cochlea 115, the compression of fixationstructure 450 by bone 160 creates the longitudinal anchor force thatprevents movement of fixation structure 450 out of cochlea 115. In suchembodiments, fixation structure 450 may comprise a flexible componentsuch as silicone, polyurethane, PTFE, etc.

In other embodiments, the longitudinal anchor force created by theinteraction of fixation structure 450 and bone 160 may be the result offriction. As electrode assembly 400 attempts to exit cochlea 115, thefriction between fixation structure 450 and bone 160 produces thelongitudinal anchor force that prevents movement of electrode assembly400. In certain embodiments, fixation structure 450 may have a rough oruneven surface that increases friction with bone 160.

As would be understood to those of ordinary skill in the art, the bonesurrounding facial recess 362 is typically not a smooth surface, andlikely has burrs and marks resulting from its interaction with surgicaltools, as well due to the structural features of bone 160. For example,bone 160 naturally includes aerated sections that form openings in thebone. Such attributes of bone 160 tend to increase the friction betweenfixation structure 450 and bone 160. In further embodiments, the surfaceof bone 160 may be purposefully scored to further increase the frictionwith fixation structure 450.

Fixation structure 450 may comprise a flexible component as describedabove. In an alternative embodiment, fixation structure 450 may comprisea malleable material such as a metal or a hard plastic or a shape-memorymaterial that changes shape upon heating to body temperature or othercatalyst such has IR or UV light, to anchor itself into the recess inbone 160. In such embodiments fixation structure 450 may comprisematerials such as titanium, platinum, stainless steel, chromium,nitinol, etc. In one particular embodiment, the shape-memory materialcomprises a shape-memory polymer.

FIGS. 5A-5H depict various embodiments of fixation structure 250 (FIGS.2A, 2B) which may take advantage of the non-smooth surface of bone 160to increase the longitudinal and/or rotational anchor forces created bythe interaction of the two. For example, in certain embodiments,fixation structure 250 comprises non-smooth surfaces that may protrudeinto openings or burs within bone 160 to further engage bone 160. As theuneven surfaces of such fixation structures 250 protrude into openingsin bone 160, the uneven surface interlocks with bone 160. Thisinterlocking creates longitudinal anchor force that prevents substantiallongitudinal movement of such embodiments of fixation structure 250 andthereby physically retaining carrier member 202 (FIGS. 2A, 2B) in adesired position in cochlea 115.

In alternative embodiments, fixation structure 250 may comprise amalleable material, as described above. In such embodiments, in additionto the friction force created between fixation structure 250 and bone160, the pressure exerted on bone 160 by the malleable material may,over time, cause fixation structure 250 to cut into bone 160, causingfixation structure 250 to interlock with bone 160. This interlockingcreates a longitudinal anchor force that prevents substantiallongitudinal movement of such embodiments of fixation structure 250thereby physically retaining carrier member 202 (FIGS. 2A, 2B) in adesired position in cochlea 115.

In further embodiments, fixation structure 250 may be configured ortreated to facilitate the in-growth of bone 160 to fixation structure250, further increasing the longitudinal and rotational anchor forces.

As would be appreciated by one of ordinary skill in the art,circumferentially-extending projections of embodiments of fixationstructure 250 such as projections 470 of fixation structure 450 do notnecessarily interact with bone 160 at all surfaces of bone 160. Forexample, fixation structure 450 may be positioned in facial recess 362such that circumferentially-extending projections 470 interact with one,two, three or more surfaces of bone 160. Accordingly, in alternativeembodiments, projections may not circumferentially extend around theentire perimeter of fixation structure 250.

Alternatively, fixation structure 250 may be made of a hydrogel materialto expand and lock into the slot in the bone. Preferably, the expansionof such an embodiment of fixation structure 250 is controllable so thatthe timing of swelling is determined by the surgeon. This may beattained, for example, by pulling a “plug” on fixation structure 250 tolet moisture reach the hydrogel, or by piercing an outer silicone casingof 250 to let moisture through.

The various embodiments of fixation structure 250 may also beconstructed and arranged to prevent rotation of electrode assembly 200.As noted, such embodiments, fixation structure 250 interacts with bone160 to produce a rotational anchor force. The rotational anchor forcemay be created by any manner described above. For example, a rotationalanchor force may be created by friction between bone 160 and fixationstructure 250, or by the interlocking of fixation structure 250 and bone160.

FIGS. 5A-5H each illustrate cross-sectional and (left) (right) sideviews of different embodiments of fixation structure 250. FIG. 5Aillustrates one alternative embodiment of fixation structure 250,referred to as fixation structure 250A. Fixation structure 250A has agenerally spherical shape that substantially surrounds carrier member202. As shown with reference to cross-sectional plane 588, sphericalfixation structure 250A has an approximately circular cross section,with the center of spherical fixation structure 250A positioned on alongitudinal axis 539 extending through the center of carrier member202. Spherical fixation structure 250A is dimensioned such that at leasta portion of the outer surface of spherical fixation structure 450A isin contact with bone 160 following implantation of electrode assembly200.

The interaction of bone 160 and spherical fixation structure 250Aproduces a longitudinal anchor force that substantially maintainsfixation structure 250A in a desired location relative to bone 160. Asfixation structure 250A is maintained in the desired location, carriermember 202 is, as noted, substantially prevented from longitudinalmovement toward or away from cochlea 115. Also as described above, thislongitudinal anchor force may be the result of several differentinteractions between spherical fixation structure 250A and bone 160. Forexample, in one embodiment, the longitudinal anchor force resulting fromthe interaction between spherical fixation structure 450A and bone 160may be the result of friction between the two surfaces. However, aswould be appreciated by one of ordinary skill in the art, fixationstructure 250A may be configured to interact with bone 160 in any mannerdescribed herein to produce the longitudinal anchor force.

FIG. 5B illustrates another embodiment of fixation structure 250,referred to as fixation structure 250B. Fixation structure 250Bcomprises a pair of radially-extending projections 572.Radially-extending projections 572 are positioned, in this embodiment,approximately 180 degrees relative to each other and lie in a planeillustrated in FIG. 5B as plane 590. Plane 590 extends laterally andlongitudinally through the center of carrier member 202. Viewingradially-extending projections 572 within plane 592, radially-extendingprojections 572 each have, in this example, a substantially rectangularcross section. Radially-extending projections 572 have a length that isparallel to carrier member 202 and a width that is perpendicular tocarrier member 202, with the length being greater than the width.Radially-extending projections 572 are dimensioned to interact with bone160 on opposing sides of carrier member 202.

The interaction of bone 160 and radially-extending projections 572produces a longitudinal anchor force that substantially maintainsfixation structure 250B in a desired fixed location relative to bone160. As fixation structure 250B is maintained in the desired location,carrier member 202 is, as noted, substantially prevented fromlongitudinal movement toward or away from cochlea 115. Also as describedabove, this longitudinal anchor force may be the result of severaldifferent interactions between radially-extending projections 572 andbone 160. For example, in one embodiment, the longitudinal anchor forceresulting from the interaction between radially-extending projections572 and bone 160 may be the result of friction between the outer surfaceof radially-extending projections 572 that lies parallel to, but awayfrom carrier member 202, and bone 160. In another embodiment,radially-extending projections 572 are configured to fit into thenatural openings in bone 160 to maintain fixation structure 250B in adesired location. In still further embodiments, radially-extendingprojections 572 are comprised of a material that cuts into bone 160 tothereby maintain fixation structure 250B in a desired location. However,as would be appreciated by one of ordinary skill in the art,radially-extending projections 572 may be configured to interact withbone 160 in any manner described herein so as to produce the desiredlongitudinal anchor force.

In an alternative embodiment, radially-extending projections 572 may beflexibly biased so that they fold against carrier member 202 duringinsertion, and then radially extend after insertion. In one embodiment,this may be provided with shape memory material that extends uponheating to 37 C. In another embodiment, a hydrogel may be incorporatedinto projections 572 to cause the extension. Such embodiments preventradially-extending projections 572 from interfering with the surgeon'svisibility during insertion.

FIG. 5C illustrates another embodiment of fixation structure 250,referred to as fixation structure 250C. Fixation structure 250Ccomprises four radially-extending projections 574 each having anapproximately quadrilateral shape. Radially-extending projections 574are radially positioned around carrier member 202 so as to be spacedapproximately 90 degrees relative to each other. One set ofradially-extending projections 574 are positioned approximately 180degrees from each other and lie in a plane illustrated in FIG. 5C asplane 592. Plane 592 extends longitudinally through the center ofcarrier member 202. A second set of radially-extending projections 574are positioned 180 degrees from each other and lie in a planeillustrated in FIG. 5C as plane 594. Plane 594 extends longitudinallythrough the center of carrier member 202, but is substantiallyperpendicular to plane 592. Viewing radially-extending projections 574within either plane 592 or plane 594, radially-extending projections 574each have a substantially rectangular cross section with a length thatis parallel to carrier member 202 and a width that is perpendicular tocarrier member 202, wherein the length is greater than the width.Radially-extending projections 574 are dimensioned to provide contactwith bone 160 at up to four separate locations surrounding carriermember 202 following implantation of electrode assembly 200.

The interaction of bone 160 and radially-extending projections 574produces a longitudinal anchor force that substantially maintainsfixation structure 250C in a desired location relative to bone 160. Asfixation structure 250C is maintained in a desired location, carriermember 202 is securely positioned within cochlea 115 and is, as noted,prevented from longitudinal movement toward or away from cochlea 115.Also as described above, this longitudinal anchor force may be theresult of several different interactions between radially-extendingprojections 574 and bone 160. For example, in one embodiment, thelongitudinal anchor force resulting from the interaction betweenradially-extending projections 574 and bone 160 may be the result offriction between the outer surface of radially-extending projections 574that lies parallel to, but away from carrier member 202, and bone 160.In another embodiment, radially-extending projections 574 are configuredto fit into the natural openings in bone 160 to maintain fixationstructure 250C in a desired location. In still further embodiments,radially-extending projections 574 are comprised of a material thatslightly cuts into bone 160 to thereby maintain fixation structure 250Cin a desired location. However, as would be appreciated by one ofordinary skill in the art, radially-extending projections 574 may beconfigured to interact with bone 160 in any manner described herein soas to produce the desired longitudinal anchor force.

FIG. 5D illustrates another embodiment of fixation structure 250,referred to as fixation structure 250D. Fixation structure 250Dcomprises a plurality of radially-extending projections 576. In thisexemplary embodiment, there are four (4) radially-extending projections576 each radially positioned on carrier member 202 so as to be spacedapproximately 90 degrees from one another. Viewing radially-extendingprojections 576 in a cross section plane shown in FIG. 5D as plane 596,each radially-extending projection 576 has an approximately cross-shapedcross section. Within plane 596, radially-extending projections 576 eachcomprise a first approximately rectangular central region extending awayfrom carrier member 202. Extending from each of these rectangularcentral regions are two approximately square shaped regions. The squareshaped regions extend from opposing sides of the central regionsubstantially parallel to carrier member 202. As such, within plane 596each radially-extending projection 576 has the noted cross-shaped crosssection. Radially-extending projections 576 are dimensioned to interactwith bone 160 at up to four separate locations surrounding carriermember 202 following implantation of electrode assembly 200. It shouldbe appreciated, however, that more or less projections 576 may beimplemented in alternative embodiments, with such projections beenspaced apart by any distance and in any manner necessary to achieve adesired anchoring of fixation structure 250D with bone 160. For example,projections 576 may be longitudinally offset relative to each other, orhave different longitudinal lengths.

The interaction of bone 160 and radially-extending projections 576produces a longitudinal anchor force that substantially maintainsfixation structure 250D in a desired location relative to bone 160. Asfixation structure 250D is maintained in the desired location, carriermember 202 is securely positioned within cochlea 115 and is, as noted,substantially prevented from longitudinal movement toward or away fromcochlea 115. Also as described above, this longitudinal anchor force maybe the result of several different interactions betweenradially-extending projections 576 and bone 160. For example, in oneembodiment the longitudinal anchor force resulting from the interactionbetween radially-extending projections 576 and bone 160 may be theresult of friction between the outer surface of radially-extendingprojections 576 that lies parallel to, but away from carrier member 202,and bone 160. In another embodiment, radially-extending projections 576are configured to fit into the natural openings in bone 160 to maintainfixation structure 250D in a desired location. In still furtherembodiments, radially-extending projections 576 are comprised of amaterial that cuts into bone 160 to thereby maintain fixation structure250D in a desired location. However, as would be appreciated by one ofordinary skill in the art, radially-extending projections 576 may beconfigured to interact with bone 160 in any manner described herein soas to produce the desired longitudinal anchor force.

FIG. 5E illustrates another embodiment of fixation structure 250,referred to as fixation structure 250E. Fixation structure 250Ecomprises a series of longitudinally spaced disks eachcircumferentially-extending from carrier member 202. In thisillustrative embodiment, fixation structure 250E comprises a series ofthree circumferentially-extending disks 578, although other quantitiesmay be implemented. Following implantation of electrode assembly 200, asubstantial portion of the outer circumference of each disk isconfigured to interact with bone 160.

The interaction of bone 160 and the outer surface ofcircumferentially-extending disks 578 produces a longitudinal anchorforce that substantially maintains fixation structure 250E in a desiredlocation relative to cochlea 115. As fixation structure 250E ismaintained in the desired location, carrier member 202 is securelypositioned within cochlea 115 and is, as noted, substantially preventedfrom longitudinal movement toward or away from cochlea 115. Also asdescribed above, this longitudinal anchor force may be the result ofseveral different interactions between circumferentially-extending disks578 and bone 160. For example, in one embodiment the longitudinal anchorforce resulting from the interaction between one or morecircumferentially-extending disks 578 and bone 160 may be the result offriction between the outer surface of the circumferentially-extendingdisks and bone 160. In another embodiment, circumferentially-extendingdisks 578 are configured to fit into the natural openings in bone 160 tomaintain fixation structure 250E in a desired location. In still furtherembodiments, circumferentially-extending disks 578 are comprised of amaterial that slightly cuts into bone 160 to thereby maintain fixationstructure 450E in a desired location. However, as would be appreciatedby one of ordinary skill in the art, circumferentially-extending disks578 may be configured to interact with bone 160 in any manner describedherein so as to produce the desired longitudinal anchor force.

FIG. 5F illustrates another embodiment of fixation structure 250,referred to as fixation structure 250F. Fixation structure 250Fcomprises a cylindrical extension radially extending from carrier member202. As shown with reference to cross sectional plane 591, cylindricalfixation structure 250F has an approximately circular cross section,with its center positioned on longitudinal axis 549 extending throughthe center of the length of carrier member 202. The diameter ofcylindrical fixation structure 250F is substantially constant, althoughit may vary in alternative embodiments of the invention. Cylindricalfixation structure 250F is shaped and sized such that at least a portionof the outer surface of cylindrical fixation structure 250F is incontact with bone 160 following implantation of electrode assembly 400.

The interaction of bone 160 and cylindrical fixation structure 250Fproduces a longitudinal anchor force that substantially maintainsfixation structure 250F in a desired fixed location relative to bone160. As fixation structure 250F is maintained in the desired location,carrier member 202 is secured within cochlea 115 and is, as noted,substantially prevented from longitudinal movement toward or away fromcochlea 115. Also as described above, this longitudinal anchor force maybe the result of several different interactions between cylindricalfixation structure 450F and bone 160. For example, in one embodiment thelongitudinal anchor force resulting from the interaction betweencylindrical fixation structure 450F and bone 160 may be the result offriction between the two surfaces. However, as would be appreciated byone of ordinary skill in the art, fixation structure 250F may beconfigured to interact with bone 160 in any manner described above withreference to FIG. 4 to produce the longitudinal anchor force.

FIG. 5G illustrates another embodiment of fixation structure 250,referred to as fixation structure 250G. Fixation structure 250Gcomprises a series of circumferentially-extending projections 582. Aplane 595 extends longitudinally through the center of carrier member202. Viewing a circumferentially-extending projection within plane 595,each projection 582 has a cross section that includes three sides. Thefirst side of the cross section is adjacent to, and parallel to carriermember 202. The other two sides of the cross section comprise a firstarcuate slope joined to a second slope that is substantiallyperpendicular to carrier member 202 by a substantially rounded apexpositioned apart from the first side of the cross section. Viewing acircumferentially-extending projection 582 within plane 593, theprojection has an approximately circular cross section.

The interaction of bone 160 and circumferentially-extending projections582 produces longitudinal anchor force that substantially maintainsfixation structure 250G in a desired fixed location relative to cochlea115. As fixation structure 250G is maintained in the desired location,carrier member 202 is, as noted, substantially prevented fromlongitudinal movement toward or away from cochlea 115. Also as describedabove, this longitudinal anchor force may be the result of severaldifferent interactions between circumferentially-extending projections582 and bone 160. For example, in one embodiment the longitudinal anchorforce resulting from the interaction between circumferentially-extendingprojections 582 and bone 160 may be the result of friction between theouter surface of circumferentially-extending projections 582 and bone160. In another embodiment, portions of circumferentially-extendingprojections 582, particularly the rounded apex of each cross section,are configured to fit into the natural openings in bone 160 to maintainfixation structure 250G in a desired location relative to bone 160. Instill further embodiments, circumferentially-extending projections 582are comprised of a material that slightly cuts into bone 160 to therebymaintain fixation structure 250G in a desired location. However, aswould be appreciated by one of ordinary skill in the art,circumferentially-extending projections 582 may be configured tointeract with bone 160 in manner described above with reference to FIG.4 so as to produce the desired longitudinal anchor force.

FIG. 5H illustrates another embodiment of fixation structure 250,referred to as fixation structure 250H. Fixation structure 250Hcomprises a generally cylindrical shape extending from carrier member202. The diameter of cylindrical shaped fixation structure 450H variesalong the length of carrier member 202 to produce a wavy-shaped surfaceof fixation structure 250H. As shown with reference to cross sectionalplane 591, cylindrical fixation structure 250H has a generally circularcross section having its center positioned on the longitudinal axis 559extending through the center of the length of carrier member 202, butwith a diameter that varies. Cylindrical fixation structure 250H isshaped and sized such that at least a portion of the outer surface ofcylindrical fixation structure 250H is in contact with bone 160following implantation of electrode assembly 400.

The interaction of bone 160 and cylindrical fixation structure 250Hproduces a longitudinal anchor force that substantially maintainsfixation structure 250H in a desired fixed location relative to cochlea115. As fixation structure 450H is maintained in the desired location,carrier member 202 is, as noted, prevented from longitudinal movementtoward or away from cochlea 115. Also as described above, thislongitudinal anchor force may be the result of several differentinteractions between cylindrical fixation structure 250H and bone 160.For example, in one embodiment the longitudinal anchor force resultingfrom the interaction between cylindrical fixation structure 250H andbone 160 may be the result of friction between the two surfaces. Inanother embodiment, portions of circumferentially-extending projections582 are configured to fit into the natural openings in bone 160 tomaintain fixation structure 250H in a desired location. However, aswould be appreciated by one of ordinary skill in the art, fixationstructure 250H may be configured to interact with bone 160 in any mannerdescribed above with reference to FIG. 4 to produce the longitudinalanchor force.

As would be appreciated by one of ordinary skill in the art, theembodiments described with reference to FIGS. 5A-5H are equally capableof producing the rotational anchor force to thereby prevent rotationalmovement of carrier member 202 within cochlea 115.

FIG. 6 is a perspective view of the right side of a recipientdemonstrating the location of implantation of an electrode assembly inaccordance with certain of the embodiments shown in FIGS. 7A-8D. Asdescribed above with reference to FIG. 3, facial recess 662 is locatedbetween the facial nerve 310 and the cord-tympani nerve 312. Facialnerve 310 is positioned posterior to facial recess 662, and cord-tympaninerve 312 is positioned anterior to facial recess 662. Visible behindfacial recess 662 is round window 141 of cochlea 115.

In the embodiment shown in FIG. 6, facial recess 662 has a narrow slot670 on the inferior side of facial recess 662. Slot 670 forms a channelrunning from facial recess 662 in an inferior direction. As shown inFIG. 6, facial recess 662 is a contiguous opening that has anapproximately clithridiate, or key-hole shape.

FIG. 7A is a side view of one embodiment of electrode assembly 140,referred to herein as electrode assembly 700, shown in an implantedconfiguration via facial recess 662 illustrated in FIG. 6. In FIG. 7A,cochlea 115 and electrode assembly 700 are viewed from the anteriordirection of the recipient.

Electrode assembly 700 comprises a carrier member 202, having proximalend 208 and distal end 210, terminating in tip 211. A plurality ofspaced-apart electrodes 212 are mounted on or in carrier member 202along medial surface 216 of carrier member 202. The opposing side ofcarrier member 202 is referred to herein as lateral surface 218. Lead214 extends from proximal end 208 to stimulator unit 134 (FIG. 1).

Attached to or integral with carrier member 202 are stop member 240 asdescribed herein with reference to FIGS. 2A and 2B, and fixationstructure 750. Fixation structure 750 is positioned at or near proximalend 208 of carrier member 202 to substantially interact with at least aportion of the bone surrounding facial recess 362. Illustrativeembodiments of fixation structure 750 are described below with referenceto FIGS. 8A-8D.

As described above, in embodiments utilizing facial recess 362, asurgeon inserts electrode assembly 700 through bone 160, across middleear 102 and into cochlea 115 through round window 141 until stop element240 contacts cochlea 115. Stop element 240 is substantially similar asdescribed above with reference to FIGS. 2A and 2B.

After stop element member 240 contacts cochlea 115, the surgeonpositions proximal end 208 of carrier member 202 into slot 670 of facialrecess 662. As shown in FIG. 7A, fixation structure 750 is positioned oncarrier member 202 such that after placement of proximal end 208 intoslot 670, fixation structure 750 contacts bone 160 surrounding slot 670.

As described above, an implanted electrode assembly has a tendency toexit cochlea 115 following implantation. In the illustrated embodiment,as electrode assembly 700 attempts to exit cochlea 115, fixationstructure 750 is pressed against bone 160. As such, fixation structure750 interacts with bone 160 and a longitudinal anchor force is exertedon electrode assembly 700 in the direction of cochlea 115. Thislongitudinal anchor force thereby securely locks carrier member 202 intoa desired position within cochlea 115 by preventing if from exiting thecochlea. To remove carrier member 202 from cochlea 115, a surgeon maylift proximal end 208 of carrier member 202 from slot 670 and exitfixation structure 750 through facial recess 662.

FIG. 7B is an alternative view of the electrode assembly illustrated inFIG. 7A spiraling into cochlea 115. In FIG. 7B, electrode assembly 700and cochlea 115 are viewed from a superior direction of the recipient.Cochlea 115 spirals to the apex 762 of cochlea 115.

As noted above, electrode assemblies in accordance with certainembodiments of the present invention include half-band electrodes. Foroptimal stimulation, an electrode assembly utilizing half-bandelectrodes is preferably maintained in both a desired position andorientation within cochlea 115. As such, in additional embodiments,carrier member 202 and fixation structure 750 may be configured tocollectively lock electrode assembly 700 into both a desired positionand orientation in cochlea 115. In such embodiments, proximal end 208may comprise planar surfaces on at least two parallel edges of carriermember 202, shown in FIG. 7B as parallel planar surfaces 790. Proximalend 208 having surfaces 790 is placed into slot 670 with surfaces 790each abutting and parallel to bone 160 that partially surrounds slot670. Once placed within slot 670, if carrier member 202 would attempt totwist within cochlea 115, surfaces 790 would be forced against bone 160.The interaction of bone 160 and surfaces 790 produces a rotationalanchor force that prevents axial rotation of carrier member 202.

FIGS. 8A-8D are cross section and side views of embodiments of afixation structure 750 in accordance with embodiments of the presentinvention, as described with reference to FIGS. 7A and 7B. Specifically,the fixation structures shown in FIGS. 8A-8D may be utilized to lockcarrier member 202 into cochlea 115.

FIG. 8A illustrates one embodiment of fixation structure 750, referredto as fixation structure 850A. Fixation structure 850A has a generallyspherical shape that substantially surrounds carrier member 202. Asshown with reference to cross sectional plane 890, spherical fixationstructure 850A has an approximately circular cross section, with thecenter of spherical fixation structure 850A positioned on thelongitudinal axis 819 extending through the center of the length ofcarrier member 202. Spherical fixation structure 850A is dimensionedsuch that at least a portion of the outer surface of spherical shapedfixation structure 850A is in contact with bone 160 followingimplantation of electrode assembly 700. Any movement of carrier member202 out of cochlea 115 is prevented by a longitudinal anchor force backtowards cochlea 115 that is produced by the interaction of bone 160 andspherical shaped fixation structure 850A. Spherical shaped fixationstructure 850A may be of any diameter that is sufficient to achievedesired interaction with bone 160. For example, spherical shapedfixation structure 850A may have a diameter that is larger than thewidth of slot 670.

FIG. 8B illustrates another embodiment of fixation structure 750,referred to as fixation structure 850B. Fixation structure 850B has adiamond shape that substantially surrounds carrier member 202. As shownwith reference to cross sectional plane 892, diamond shaped structure850B has an approximately diamond cross section, and is positioned suchthat the longitudinal axis 829 extending through the center of thelength of carrier member 202 also extends through the center of fixationstructure 850B. Diamond shaped fixation structure 850B is dimensionedsuch that at least a portion of the outer surface of fixation structure850B is in contact with bone 160 following implantation of electrodeassembly 700. Any movement of carrier member 202 out of cochlea 115 isprevented by a longitudinal anchor force back towards cochlea 115produced through the interaction of bone 160 and diamond shaped fixationstructure 750B. Diamond shaped fixation structure 750B may have anydimensions that are sufficient to achieve desired interaction with bone160. For example, the distance between the center of diamond shapedfixation structure 750B and any vertex of the diamond may be larger thanthe width of slot 670.

FIG. 8C illustrates a further embodiment of fixation structure 250,referred to as fixation structure 850C. Fixation structure 850C has agenerally cube or cuboidal shape that substantially surrounds carriermember 202. As shown with reference to cross sectional plane 890,spherical fixation structure 850C has an approximately square crosssection, with the center of spherical fixation structure 850C positionedthe longitudinal axis 839 extending through the center of the length ofcarrier member 202. Fixation structure 850C is shaped and sized suchthat at least a portion of the outer surface of cuboidal fixationstructure 850C is configured to be in contact with bone 160 followingimplantation of electrode assembly 400. Any movement of carrier member202 out of cochlea 115 is prevented by a longitudinal anchor force backtowards cochlea 115 produced through the interaction of bone 160 andcuboidal shaped fixation structure 850C. Cuboidal fixation structure850C may be of any height 898 and width 896 that is sufficient toachieve desired interaction with bone 160. For example, cuboidal shapedfixation structure 850C may have a height 898 and width 896 that islarger than the width of slot 670.

FIG. 8D illustrates a still other embodiment of fixation structure 250,referred to as fixation structure 850D. Fixation structure 850Dcomprises four radially-extending projections 870 each having anapproximately quadrilateral shape. For example, in the illustratedembodiment, radially-extending projections 870 each have anapproximately rectangular cross section as described below.Radially-extending projections 870 are positioned approximately 90degrees from each other. One set of radially-extending projections 870are positioned approximately 180 degrees from each other and lie in aplane illustrated in FIG. 8D as plane 893. A second set ofradially-extending projections 870 are positioned 180 degrees from eachother and lie in a plane illustrated in FIG. 8D as plane 891. Plane 891extends longitudinally through the center of carrier member 202, but issubstantially perpendicular to plane 893. Viewing radially-extendingprojections 870 within either plane 893 or plane 891, radially-extendingprojections 870 each have an approximately rectangular cross section.Radially-extending projections 870 have a length that is parallel tocarrier member 202 and a width that is perpendicular to carrier member202, with the length being greater than the width. Radially-extendingprojections 870 are shaped and sized to provide contact with bone 160 atfour separate locations surrounding carrier member 202 followingimplantation of electrode assembly 400. Any movement of carrier member202 out of cochlea 115 is prevented by a longitudinal anchor force backtowards cochlea 115 produced through the interaction of bone 160 andradially-extending projections 870. Radially-extending projections 870have sufficient length and width to prevent carrier member 202 fromexiting through slot 670.

As described above with reference to FIGS. 7A and 7B, the embodimentsillustrated in FIGS. 8A-8D may be further modified to prevent rotationof carrier member 202.

As would be appreciated by one of ordinary skill in the art, fixationstructure 750 may comprise any shape or element that serves to interactwith bone 160 to prevent longitudinal movement of carrier member 202 outof cochlea 115. For example, fixation structure 750 may comprise any ofthe embodiments of fixation structure 450 illustrated in FIGS. 5A-5H.All of the embodiments illustrated in FIGS. 5A-5H, utilized as describedwith reference to FIGS. 7A and 7B, would serve to interact with thecochlea-side of bone 160 to lock carrier member 202 into cochlea 115.Similarly, other embodiments for fixation structure 750 may beenvisioned that have not been illustrated herein.

As would be further appreciated, in certain embodiments fixationstructure 750 may comprise flexible materials such as silicone,polyurethane, PTFE, rubber etc. In alternative embodiments, fixationstructure may comprise a malleable material such as metals or hardplastics. Specifically, the fixation structure may comprise materialssuch as titanium, platinum, stainless steel, chromium, nitinol etc.

In other aspects of the present invention utilizing embodiments offixation structure 750, a surgeon does not cut slot 670 into a recipientprior to implantation of electrode assembly 700. Rather, a surgeon maydesire to implant a bracket in the recipient to interact with fixationstructure 750. FIGS. 9A and 9B illustrate partially cross sectionalviews of a recipient that demonstrate the location of brackets implantedby a surgeon. The brackets can be formed of any material(s) and have anydimensions appropriate for the application. For example, in oneembodiment, the bracket is a shape memory alloy that is heated to adoptthe final desired shape.

As shown in FIG. 9A, a bracket 930A is implanted on the posterior sideof facial recess 362. Bracket 930A shown in FIG. 9A comprises a metalplate that is attached to bone 160 of the recipient with a bone screw932. Similarly, as shown in FIG. 9B, bracket 930B is also implanted onthe posterior side of facial recess 362. In this illustrated embodiment,bracket 930B comprises a malleable wire bracket secured to bone 160 withscrew 932.

As would be appreciated by one of ordinary skill in the art, bracket 930may be implanted at any location around facial recess 362 such that itat least partially extends over facial recess 362 and so long as it doesnot interfere with any nerves near facial recess 362.

FIG. 10 is a side view of one embodiment of the electrode assemblyillustrated in FIGS. 7A and 7B, referred to as electrode assembly 1000,viewed from the anterior direction of the recipient. In the illustratedembodiment, electrode assembly 1000 interacts with a bracket 1030.

Electrode assembly 1000 comprises a carrier member 202, having proximalend 208 and distal end 210, terminating in tip 211. A plurality ofspaced-apart electrodes 212 are mounted on or in carrier member 202along the medial surface 216 of carrier member 202. Lead 214 extendsfrom proximal end 208.

Attached to or integral with carrier member 202 are stop member 240 asdescribed with reference to FIGS. 2A and 2B, and an embodiment offixation structure 750, referred to herein as fixation structure 1050.Fixation structure 1050 is positioned at or near proximal end 208 ofcarrier member 202 to substantially interact with bracket 1030. As wouldbe appreciated, fixation structure 1050 may comprise any fixationstructure described above with reference to FIGS. 8A-8D and 5A-5F.

Prior to commencing implantation of electrode assembly 1000, a surgeonloosely attaches bracket 1030 to bone 160 with bone screw 1032. Bracket1030 is swung away from facial recess 362 to allow the surgeon access tofacial recess 362. As described above, in embodiments utilizing facialrecess 362, a surgeon inserts electrode assembly 1000 through bone 160,across middle ear 102 and into cochlea 115 through round window 141,until stop element 240 contacts cochlea 115. Stop element 240 issubstantially the same as described above. The surgeon then swingsbracket 1030 back over facial recess 362 and secures bracket 1030 tobone 160 with screw 1032 to prevent movement of bracket 1030. Thesurgeon then positions proximal end 208 of carrier member 202 intoreceiving slot of bracket 1030 (not shown). Fixation structure 1050 ispositioned on carrier member 202 such that after placement of proximalend 208 of carrier member 202 into the receiving slot of bracket 1030,fixation structure 1050 is in contact with bracket 1030.

As described above, an implanted electrode assembly may have a tendencyto exit cochlea 115 following implantation. In the illustratedembodiment, as electrode assembly 1000 attempts to exit cochlea 115,fixation structure 1050 is pressed against bracket 1030. As such,fixation structure 1050 interacts with bone 160 and a longitudinalanchor force is exerted on electrode assembly 700 in the direction ofcochlea 115. This longitudinal anchor force thereby locks carrier member202 into a desired position within cochlea 115 by preventing an exitthere from. To remove carrier member 202 from cochlea 115, the surgeonmust lift proximal end 208 of carrier member 202 from bracket 1020 andexit fixation structure 750 through facial recess 362.

Furthermore, as would be appreciated, carrier member 202 may be modifiedas described above with reference to FIGS. 7A and 7B to interact withbracket 1030 to prevent rotation of electrode assembly 1000 withincochlea 115.

As would be understood by one of ordinary skill in the art, stop element240 is not necessary for the present invention. In all embodiments stopelement 240 may be omitted if desired.

As would be appreciated by one of ordinary skill in the art, in theabove embodiments the fixation structures may be positioned in or on thecarrier member during manufacture of the electrode assembly. However, inalternative embodiments the fixation structure could be chosen by thesurgeon at some time following manufacture. For example, a surgeon couldchoose the fixation structure that is believed to be the most fittingfor the particular recipient during the implantation procedure. In suchembodiments, the surgeon could prepare the insertion opening, and thenfasten, attach, adhere or connect a properly shaped, sized and suitedfixation structure to fit the prepared opening. It is also envisionedthat a surgeon could attach the fixation structure prior to commencingthe implantation procedure.

All documents, patents, journal articles and other materials cited inthe present application are hereby incorporated by reference.

Although the present invention has been fully described in conjunctionwith several embodiments thereof with reference to the accompanyingdrawings, it is to be understood that various changes and modificationsmay be apparent to those skilled in the art. For example, in theexemplary application above embodiments of the present invention havebeen described in the context of a cochlear implant. It should beappreciated, however, that embodiments of the present invention may beimplemented in other medical devices now or later developed, includingthose that do not provide stimulation. Furthermore, embodiments of thepresent invention are not limited to any particular cochlear implant orcochlear implant function or modality. For example, embodiments of thepresent invention may be implemented in cochlear implants that performoperations to suppress tinnitus, provide vestibular treatments, and soon. It should further be appreciated that although in the aboveembodiments the present invention is implemented in connection with anelectrode carrier member, embodiments of the present invention may beimplemented in connection with other types of carrier members, othertypes of implantable devices and components, and so on. As anotherexample, in the embodiments of the fixation structure such as thoseillustrated in FIGS. 5E and 5G, the structure is shown to be completelywithin the facial recess. It should be appreciated, however, that inother embodiments the fixation structure has a length that enables it toextends beyond the medial wall of the recess. This will allow thestructure to expand and effectively create a lock against the medialwall of the facial recess, similar to the arrangement illustrated inFIG. 7B. It should further be appreciated that the reference structurein the recipient may not be bone as in the above exemplary applications.And, as noted above, it need not be biological. It may be man-made, or acombination of a man-made material injected into, applied to the surfaceof or otherwise used to treat a biological structure. Also, the rigidityof the reference structure may vary depending on, for example, thepermissible movement of the controlled medical device; for example, theelectrode carrier member in the above examples. Such changes andmodifications are to be understood as included within the scope of thepresent invention as defined by the appended claims, unless they departthere from.

What is claimed is:
 1. A method, comprising: obtaining an electrodeassembly including an electrode array and a lead assembly extending fromthe electrode array; obtaining access to an internal location of arecipient proximate a cochlea of the recipient; fixing a bracket totissue of the recipient inside the recipient; inserting the electrodearray into the cochlea; and connecting the electrode assembly directlyto the bracket so as to restrain the electrode assembly from movement.2. The method of claim 1, wherein: the action of connecting the bracketto tissue of the recipient is executed prior to the action of insertingthe electrode array into the cochlea.
 3. The method of claim 1, wherein:the action of connecting the electrode assembly to the bracket preventsthe electrode array from rotating within the cochlea after theattachment.
 4. The method of claim 1, wherein: the action of fixing thebracket to tissue includes a first sub-action including looselyattaching bracket to bone so that the bracket can move and a subsequentsecond sub-action including securing the bracket to the bone so that thebracket will not move, wherein the action of inserting the electrodearray into the cochlea is executed between the first sub-action and thesecond sub-action.
 5. The method of claim 1, wherein: the action ofinserting the electrode array into the cochlea is executed before theaction of fixing the bracket to tissue is fully completed.
 6. The methodof claim 1, wherein: the action of connecting the electrode assemblydirectly to the bracket is executed after the action of inserting theelectrode array into the cochlea.
 7. The method of claim 1, wherein: theaction of connecting the bracket to tissue of the recipient includes theaction of securing the bracket to bone of the recipient; and the actionof securing the bracket to bone of the recipient is executed after theaction of inserting the electrode array into the cochlea.
 8. The methodof claim 7, wherein: the action of connecting the electrode assemblydirectly to the bracket is executed after the action of inserting theelectrode array into the cochlea.
 9. An assembly, comprising: anelectrode assembly for implantation into a recipient, the recipientincluding a reference structure that is external to a cochlea of therecipient and comprises a substantially rigid biological structure, theelectrode assembly comprising an elongate electrode array electrodeassembly including an intra-cochlear portion including at least oneelectrode and an extra-cochlear portion; a bracket attached to theelectrode assembly, wherein the bracket is configured to be attached tothe biological structure so as to hold the portion of the electrodeassembly at the bracket relative to the biological structure; and astimulator unit in signal communication with the electrode assembly,wherein the bracket is located away from the stimulator unit.
 10. Anassembly, comprising: an electrode assembly for implantation into arecipient, the recipient including a reference structure that isexternal to a cochlea of the recipient and comprises a substantiallyrigid biological structure, the electrode assembly comprising anelongate electrode array including an intra-cochlear portion includingat least one electrode and an extra-cochlear portion; and a bracketattached to the electrode assembly, wherein the bracket is configured tobe attached to the biological structure so as to hold the electrodearray relative to the biological structure, and the bracket is locatedwithin a first distance from the intra-cochlear portion, the firstdistance being the length of the intra-cochlear portion.
 11. Theassembly of claim 10, wherein: the bracket is configured to clip aroundthe electrode assembly.
 12. An assembly, comprising: an electrodeassembly for implantation into a recipient, the recipient including areference structure that is external to a cochlea of the recipient andcomprises a substantially rigid biological structure, the electrodeassembly comprising an elongate electrode array including anintra-cochlear portion including at least one electrode and anextra-cochlear portion; and a bracket attached to the electrodeassembly, wherein the bracket is configured to be attached to thebiological structure so as to hold the electrode assembly relative tothe biological structure, and the bracket directly supports theelectrode assembly relative to the biological structure so that theportion directly supported by the bracket is fixed relative to thebiological structure.
 13. The assembly of claim 12, wherein: the bracketis configured to interface with a screw configured to be screwed intothe biological structure, the screw fixing the bracket to the biologicalstructure so as to attach the bracket to the biological structure. 14.The assembly of claim 12, wherein: the bracket is a plate having alength extending at least about normal to a direction of extension of alongitudinal axis of the extra-cochlear portion, wherein a width of theplate is also normal to the direction of extension of the longitudinalaxis, and wherein a thickness of the plate has a value that is smallerthan the value of the width and the length of the plate.
 15. Theassembly of claim 12, wherein: the bracket is configured to preventsubstantial rotation of the electrode array within the cochlea, when thebracket is attached to the biological structure.
 16. The assembly ofclaim 12, wherein: the electrode array includes a fixation structureconfigured to interface with the bracket so as to limit movement of theelectrode array relative to the bracket, and thus relative to thecochlea when inserted therein.
 17. An assembly, comprising: an electrodeassembly for implantation into a recipient, the recipient including areference structure that is external to a cochlea of the recipient andcomprises a substantially rigid biological structure, the electrodeassembly comprising an elongate electrode array including anintra-cochlear portion including at least one electrode and anextra-cochlear portion; and a bracket attached to the electrodeassembly, wherein the bracket is configured to be attached to thebiological structure so as to hold the electrode array relative to thebiological structure, and a lead assembly extends from theextra-cochlear portion of the electrode array, wherein the bracket isconnected to the electrode assembly between a distal end of the leadassembly, relative to the extra-cochlear portion, and a proximal end ofthe intra-cochlear portion.
 18. An assembly, comprising: a bracketconfigured to be connected to a bone via a bone screw and to beconnected to an electrode assembly of a cochlear implant so as to limitmovement of the electrode assembly relative to the bone; and anelectrode array that is part of the electrode assembly, wherein thebracket is directly attached to the electrode assembly.
 19. The deviceof claim 18, wherein: the bracket is a wire bracket.
 20. The assembly ofclaim 18, wherein: the bracket includes a first receptacle configured toreceive the bone screw so as to attach the bracket to the bone and asecond receptacle to receive the electrode assembly.
 21. The assembly ofclaim 18, wherein: the bracket is configured to be removably attached tothe electrode assembly after the electrode array is inserted into acochlea.
 22. The assembly of claim 18, wherein: an interface between theelectrode array and the bracket prevents the electrode array fromsubstantially rotating within a cochlea when inserted therein.
 23. Theassembly of claim 18, wherein: the electrode array includes structure atan extra-cochlear section of the electrode array that has a geometrythat is different from an elongate axially extending structure, whereinthe bracket interfaces with the structure at the extra-cochlear sectionso as to limit movement of the electrode array when in the cochlea. 24.The assembly of claim 18, wherein: the electrode array includes anextra-cochlear structure at an extra-cochlear portion of the electrodearray that has a dimension prominently extending in a lateral directionof the electrode array relative to other portions of the electrodearray, wherein the bracket interfaces with the structure to limitmovement of the electrode array when in the cochlea.
 25. The assembly ofclaim 18, further comprising: a stimulator unit in signal communicationwith the electrode assembly, wherein the bracket is located away fromthe stimulator unit.